The following example illustrates calculation of some of the statistics typically calculated on product stability measures.
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | Char | Req | PT.STUDYID | |
| PRODSTID | Product Stability Identifier | Char | Req | Concatenate SPTOBID with STOCONID separated with '/' | |
| SPTOBID | Unique Subject Identifier | Char | Perm | PT.SPTOBID | |
| STOCONID | Planned Treatment | Char | Perm | PT.STOCONID | |
| PTREFID | Actual Treatment | Char | Perm | PT.PTREFID | |
| PARQUAL | Parameter Qualifier | Char | Cond | Set to the item being tested | |
| PARAM | Parameter | Char | Req | Set to the parameter being captured | |
| PARAMCD | Parameter Code | Char | Req | Set to the parameter code associated with the parameter | |
| AVAL | Analysis Value | Num | Req | Calculated statistic | |
| ATPT | Analysis Timepoint | Char | Cond | PT.PTTPT | |
| ATPTN | Analysis Timepoint (N) | Num | Cond | PT.PTTPTNUM |
ADPT
| STUDYID | PRODSTID | SPTOBID | STOCONID | PTREFID | PARQUAL | PARAM | PARAMCD | AVAL | ATPT | ATPTN |
|---|---|---|---|---|---|---|---|---|---|---|
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 51.95667 | Week 0 | 1 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.025166 | Week 0 | 1 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.048437 | Week 0 | 1 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 51.72333 | Week 8 | 4 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.046188 | Week 8 | 4 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.089298 | Week 8 | 4 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 52.31333 | Week 48 | 9 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.327465 | Week 48 | 9 |
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.625969 | Week 48 | 9 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 2 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 51.95667 | Week 0 | 1 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 2 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.025166 | Week 0 | 1 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.048437 | Week 0 | 1 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 51.80333 | Week 8 | 4 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.035119 | Week 8 | 4 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.067793 | Week 8 | 4 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 52.08667 | Week 48 | 9 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.188237 | Week 48 | 9 |
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.361393 | Week 48 | 9 |
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